Product Code: KNS FDA class 2 21 CFR 876.4300

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Gastroenterology, Urology

An Endoscopic Electrosurgical Unit with or without Accessories is a device used in gastroenterology and urology to cut and coagulate tissue during endoscopic procedures using high-frequency electrical energy, applied in procedures such as polypectomy, hemostasis, and transurethral resection. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNS and it is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

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510(k)s

188

FEI Numbers

117

Registration Numbers

117

Unique Applicants

Years Active

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Basic Information

Product Code: KNS
Device Class: FDA class 2
Regulation Number: 876.4300
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 188 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260962	Sphincterotome	May 21, 2026	Substantially Equivalent	Taewoong Medical Co., Ltd.
K252388	Vanquish Water Vapor Ablation Device	Nov 26, 2025	Substantially Equivalent	Francis Medical, Inc.
K252889	Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)	Nov 25, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K250945	Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)	Oct 17, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K250351	Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)	Oct 10, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K251104	SureTome SW Sphincterotome with DomeTip	Sep 29, 2025	Substantially Equivalent	Wilson-Cook Medical
K251226	Aqua Medical RF Vapor Ablation System	Aug 08, 2025	Substantially Equivalent	Aqua Medical, Inc.
K250584	Rezum System	Jun 11, 2025	Substantially Equivalent	Boston Scientific Corporation
K242774	SpydrBlade Flex Instrument (PRD-RG1-001)	Jun 06, 2025	Substantially Equivalent	Creo Medical, Ltd.
K241855	SB Knife Jr2 (MD-47702 and MD-47702L)	Mar 26, 2025	Substantially Equivalent	Sb-Kawasumi Laboratories, Inc.
K242192	Disposable Sphincterotome	Feb 06, 2025	Substantially Equivalent	Beijing Zksk Technology Co., Ltd.
K243568	Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord	Jan 17, 2025	Substantially Equivalent	Wilson-Cook Medical, Inc.
K241271	Aqua Medical RF Vapor Ablation System	Dec 12, 2024	Substantially Equivalent	Aqua Medical, Inc.
K242061	Reusable Interface Cable 1.5 m (PRD-IFC-002)	Aug 15, 2024	Substantially Equivalent	Creo Medical, Ltd.
K232825	Disposable Sphincterotome	Mar 29, 2024	Substantially Equivalent	Jiangsu Vedkang Medical Science and Technology Co., Ltd.
K232633	Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter	Nov 28, 2023	Substantially Equivalent	Boston Scientific
K232476	Disposable Sphincterotome	Nov 07, 2023	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.
K230328	Speedboat Flush SB1 Instrument	Oct 31, 2023	Substantially Equivalent	Creo Medical, Ltd.
K233318	AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)	Oct 27, 2023	Substantially Equivalent	Boston Scientific Corporation
K233113	ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)	Oct 25, 2023	Substantially Equivalent	Starmed Co., Ltd.
K232162	Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome	Aug 14, 2023	Substantially Equivalent	Boston Scientific Corporation
K231533	Habib EndoHPB	Jun 21, 2023	Substantially Equivalent	Boston Scientific Corporation
K222421	Sphincterotome	May 03, 2023	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K223256	Optimos Cystotome	Apr 05, 2023	Substantially Equivalent	Taewoong Medical Co., Ltd.
K222542	MCB UNIT Model: V10GMCBUS	Sep 21, 2022	Substantially Equivalent	Lamidey Noury Medical
K211909	Cysto-Gastro-Sets	Jun 09, 2022	Substantially Equivalent	G-Flex Europe Sprl
K212999	Multi-Functional Electrosurgical Knife	Mar 21, 2022	Substantially Equivalent	Anrei Medical (Hangzhou) Co., Ltd.
K213627	RF Vapor System	Dec 17, 2021	Substantially Equivalent	Aqua Medical, Inc.
K210934	Sphincterotome / short-wire compatible, Sterile Sphincterotome	Dec 01, 2021	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K211282	Aqua Medical RF Vapor System	May 27, 2021	Substantially Equivalent	Aqua Medical, Inc.
K201121	Sphincterotome	Feb 05, 2021	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K200404	ORISE ProKnife	Dec 03, 2020	Substantially Equivalent	Boston Scientific Corporation
K192342	Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)	May 21, 2020	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K192905	Creo Electrosurgical System with HS1 Hemostasis Accessory	Mar 19, 2020	Unknown	Creo Medical, Ltd.
K192339	TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord	Jan 30, 2020	Substantially Equivalent	Wilson-Cook Medical, Inc.
K193039	Single Use Balloon Dilator V (with knife)	Dec 17, 2019	Substantially Equivalent	Olympus Medical Systems Corp.
K191505	Rezum System	Aug 02, 2019	Substantially Equivalent	Nxthera (A Boston Scientific Company)
K183595	Aqua Medical RF Vapor System	Jun 21, 2019	Substantially Equivalent	Aqua Medical, Inc.
K182408	Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645	May 15, 2019	Substantially Equivalent	Olympus Medical Systems Corp.
K190621	SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long	Apr 23, 2019	Substantially Equivalent	Sumitomo Bakelite Co., Ltd.
K181758	ELRA Electrode	Apr 11, 2019	Substantially Equivalent	Starmed Co., Ltd.
K190093	Rezum Delivery Device, Rezum Generator	Mar 25, 2019	Substantially Equivalent	Nxthera (A Boston Scientific Company)
K172665	Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords	May 24, 2018	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy
K172288	Fusion OMNI Sphincterotome	Apr 17, 2018	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy
K180165	Habib EndoHPB	Mar 20, 2018	Substantially Equivalent	Emcision , Ltd.
K180237	Rezum System	Feb 27, 2018	Substantially Equivalent	Nxthera, Inc.
K173559	Barrx SB RFA Endoscopic Catheter	Jan 18, 2018	Substantially Equivalent	Covidien, LLC
K171158	Single Use Electrosurgical knife	Nov 17, 2017	Substantially Equivalent	Olympus Medical Systems Corp.
K171993	Zimmon Needle Knife Papillotome	Aug 17, 2017	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy
K171983	Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory	Aug 17, 2017	Substantially Equivalent	Creo Medical, Ltd.
K152771	SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long	Jun 17, 2016	Substantially Equivalent	Sumitomo Bakelite Co., Ltd.
K160417	Rezum System	Mar 17, 2016	Substantially Equivalent	Nxthera, Inc.
K160241	Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215	Mar 02, 2016	Substantially Equivalent	Olympus Medical Systems Corp.
K150142	Single Use Balloon Dilator V (with Knife)	Oct 08, 2015	Substantially Equivalent	Olympus Medical Systems Corp.
K150786	Rezum System	Aug 27, 2015	Substantially Equivalent	Nxthera, Inc.
K141991	SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP	Mar 31, 2015	Substantially Equivalent	Olympus Medical Systems Copr.
K133933	INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER	Apr 02, 2014	Substantially Equivalent	Boston Scientific Corporation
K130623	BARRX CHANNEL RFA ENDOSCOPIC CATHETER	Jul 26, 2013	Substantially Equivalent	Covidien, LLC
K122505	SINGLE USE PRELOADED SPHINCTEROTOME V	Apr 11, 2013	Substantially Equivalent	Olympus Medical Systems Corp.
K123319	GYRUS ACMI BICOAG HEMOSTASIS PROBE	Dec 14, 2012	Substantially Equivalent	Olympus Surgical Technologies America
K122203	TRUETOME	Aug 17, 2012	Substantially Equivalent	Boston Scientific Corp
K110887	INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER	Apr 14, 2011	Substantially Equivalent	Boston Scientific Corporation
K092571	GYRUS ACMI BIOCOAG PROBE	Oct 20, 2010	Substantially Equivalent	Gyrus Acmi, Inc.
K102273	MERIT BIPOLAR COAGULATION PROBE	Sep 07, 2010	Substantially Equivalent	Merit Medical Systems, Inc.
K093079	TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U	Aug 02, 2010	Substantially Equivalent	Hobbs Medical, Inc.
K101139	PROSTIVA RF THERAPY MODEL 8929 HAND PIECE	May 21, 2010	Substantially Equivalent	Medtronic, Inc.
K092309	SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L	Oct 30, 2009	Substantially Equivalent	Olympus Medical Systems Corporation
K083292	HABIB ENDOHPB	Jun 10, 2009	Substantially Equivalent	Emcision , Ltd.
K083275	PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2	Jun 09, 2009	Substantially Equivalent	Max Endoscopy, Inc.
K082114	ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00	Dec 19, 2008	Substantially Equivalent	Apollo Endosurgery, Inc.
K082464	PROSTIVA RF THERAPY HAND PIECE, MODEL 8929	Oct 27, 2008	Substantially Equivalent	Medtronic, Inc.
K080946	CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX	May 20, 2008	Substantially Equivalent	Conmed Endoscopic Technologies, Inc.
K072383	HABIB ENDOBLATE	Nov 29, 2007	Substantially Equivalent	Emcision , Ltd.
K061684	MEDI-GLOBE ROTA-CUT SPHINCTEROTOME	Jun 27, 2006	Substantially Equivalent	Medi-Globe Corporation
K052413	TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934	Nov 17, 2005	Substantially Equivalent	Medtronic Vascular
K052051	OMNI SPHINCTEROTOME	Aug 05, 2005	Substantially Equivalent	Wilson-Cook Medical, Inc.
K050578	COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE	Apr 22, 2005	Substantially Equivalent	Cook Ireland, Ltd.
K033135	STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM	Aug 09, 2004	Substantially Equivalent	Stryker Endoscopy
K040981	USW NEEDLEKNIFE PAPILLOTOME	May 07, 2004	Substantially Equivalent	Wilson-Cook Medical, Inc.
K033203	WILSON-COOK TRI-TOME SELECT PLUS	Dec 19, 2003	Substantially Equivalent	Wilson-Cook Medical, Inc.
K031026	ETI BIPOLAR HEMOSTATIC PROBE	Jun 27, 2003	Substantially Equivalent	Endo-Therapeutics, Inc.
K030194	XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT	Mar 24, 2003	Substantially Equivalent	The Olympus Optical Co.
K030315	MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM	Feb 27, 2003	Substantially Equivalent	Ultroid, LLC
K023706	ULTROID HEMORRHOID MANAGEMENT SYSTEM	Jan 14, 2003	Substantially Equivalent	Ultroid, LLC
K022595	WILSON-COOK CYSTOTOME	Oct 17, 2002	Substantially Equivalent	Wilson-Cook Medical, Inc.
K021266	ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018	Sep 27, 2002	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K012587	RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE	Dec 11, 2001	Substantially Equivalent	Vidamed, Inc.
K013153	AUTOTOME RX MODEL # 4515, 4516	Oct 19, 2001	Substantially Equivalent	Boston Scientific Corp
K011787	PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE	Jul 06, 2001	Substantially Equivalent	Vidamed, Inc.
K010568	ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM	Mar 27, 2001	Substantially Equivalent	Arthrocare Corp.
K002583	TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM	Feb 13, 2001	Substantially Equivalent	Vidamed, Inc.
K002236	HORIZONS PAPILLOTOME	Jan 23, 2001	Substantially Equivalent	Horizons Intl. Corp.
K003569	PLASMAKINETIC ENDOUROLOGY SYSTEM	Dec 19, 2000	Substantially Equivalent	Gyrus Medical , Ltd.
K002802	RAPID EXCHANGE TAPERTOME	Oct 05, 2000	Substantially Equivalent	Boston Scientific Corp
K000508	THERMOFLEX SYSTEM	Apr 18, 2000	Substantially Equivalent	Argomed, Inc.
K994166	GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE	Dec 27, 1999	Substantially Equivalent	Gyrus Medical , Ltd.
K992402	5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH	Dec 22, 1999	Substantially Equivalent	Telemed Systems, Inc.
K991847	THERMOFLEX SYSTEM	Aug 26, 1999	Substantially Equivalent	Argomed, Inc.
K990628	GYRUS ENDOUROLOGY SYSTEM	Jun 29, 1999	Substantially Equivalent	Gyrus Medical , Ltd.
K990852	COOPERSURGICAL INFRARED COAGULATOR	Jun 11, 1999	Substantially Equivalent	CooperSurgical, Inc.
K990850	COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL	Jun 01, 1999	Substantially Equivalent	CooperSurgical, Inc.
K990376	BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME	May 03, 1999	Substantially Equivalent	Ballard Medical Products
K990855	COOPERSURGICAL INFRARED COAGULATOR FOR ENT	Mar 30, 1999	Substantially Equivalent	CooperSurgical, Inc.
K990145	WILSON-COOK BIPOLAR PROBE	Mar 25, 1999	Substantially Equivalent	Wilson-Cook Medical, Inc.
K982557	BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES	Sep 10, 1998	Substantially Equivalent	Bard Interventional Products Div.
K982289	HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##	Aug 19, 1998	Substantially Equivalent	Olympus America, Inc.
K974168	COOPERSURGICAL INFRARED COAGULATOR	Jan 23, 1998	Substantially Equivalent	Hogan & Hartson
K973826	SPHINCTEROTOME	Dec 05, 1997	Substantially Equivalent	Boston Scientific Corp
K973366	COBRA HAND PIECE	Nov 26, 1997	Substantially Equivalent	Vidamed, Inc.
K972674	WILSON-COOK NEEDLE KNIFE PAPILLOTOME	Aug 15, 1997	Substantially Equivalent	Wilson-Cook Medical, Inc.
K970945	ANGLED TIP POLYPECTOMY SNARE	May 07, 1997	Substantially Equivalent	United States Endoscopy Group, Inc.
K970278	MICROVASIVE GOLD PROBE	Apr 11, 1997	Substantially Equivalent	Boston Scientific Corp
K970053	ULTRATOMERX	Mar 28, 1997	Substantially Equivalent	Boston Scientific Corp
K963484	BARD HIGH FLOW PAPILLOTOME	Nov 19, 1996	Substantially Equivalent	Bard Interventional Products Div.
K962083	KARL STORZ REMORGIDA FORCEPS	Nov 01, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K962346	PAPILLOTOME	Aug 08, 1996	Substantially Equivalent	United States Endoscopy Group, Inc.
K960231	SPHINCTEROTOME	Jul 31, 1996	Substantially Equivalent	Lighthouse Medical, Inc.
K961762	REUSABLE ENDOSCOPIC ACCESSORY HANDLE	Jul 22, 1996	Substantially Equivalent	United States Endoscopy Group, Inc.
K961349	INJECTION GOLD PROBE	May 15, 1996	Substantially Equivalent	Boston Scientific Corp
K955247	OLYMPUS KD SERIES SPHINCTEROTOME	Apr 30, 1996	Substantially Equivalent	Olympus America, Inc.
K946109	CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS	Nov 21, 1995	Substantially Equivalent	Cabot Medical Corp.
K943629	GIP/MEDI-GLOBE PAPILLOTOME	May 26, 1995	Substantially Equivalent	Medi-Globe Corp.
K950836	REDFIELD INFRARED COAGULATOR	Mar 24, 1995	Substantially Equivalent	Hogan & Hartson
K950166	OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE	Feb 22, 1995	Substantially Equivalent	Olympus America, Inc.
K945764	HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP	Jan 30, 1995	Substantially Equivalent	Aaron Medical Industries
K944955	AESCULAP THORACOSCOPIC INSTRUMENTS	Nov 09, 1994	Substantially Equivalent	Aesculap, Inc.
K942301	MICROVASIVE INJECTION GOLD PROBE	Nov 02, 1994	Substantially Equivalent	Boston Scientific Corp
K932293	CABOT MEDICAL BIPOLAR CUTTING FORCEPS	Jul 27, 1994	Substantially Equivalent	Cabot Medical Corp.
K941728	MONOPOLAR COAGULATING POLYPECTOMY SNARE	Jun 27, 1994	Substantially Equivalent	Endoscopic Innovations, Inc.
K942068	AMERICAN CATHETER SPHINCTEROTOME	Jun 24, 1994	Substantially Equivalent	Intl. Medical, Inc.
K934315	ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME	Feb 28, 1994	Substantially Equivalent	Endovations
K921029	DOBBHOFF BIPOLAR ADAPTER	May 06, 1992	Substantially Equivalent	Biosearch Medical Products, Inc.
K920089	MONOPOLAR COAGULATING POLYPECTOMY SNARE	Mar 31, 1992	Substantially Equivalent	Everest Medical Corp.
K915408	BIPOLAR ENDOSTASIS PROBE, BEST (TM)	Mar 11, 1992	Substantially Equivalent	Medical Devices, Inc.
K913881	ENDOSTAT ELECTROSURGICAL UNIT	Nov 01, 1991	Substantially Equivalent	Medical and Scientific Enterprises, Inc.
K912129	DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE	Aug 07, 1991	Substantially Equivalent	Biosearch Medical Products, Inc.
K911648	REDFIELD INFRARED COAGULATOR	Jul 11, 1991	Substantially Equivalent	Redfield Corp.
K911600	ILCO INFRARED LIGHT COAGULATOR	Jul 09, 1991	Substantially Equivalent	Holl Meditronics, Inc.
K911700	MONOPOLAR POLLYPECTOMY SNARE	Jul 01, 1991	Substantially Equivalent	Everest Medical Corp.
K912601	BIPROBE(TM)	Jun 20, 1991	Substantially Equivalent	C.R. Bard, Inc.
K903323	RESECTOSCOPE LOOPS	Oct 01, 1990	Substantially Equivalent	Olympus Corp.
K901443	ZIMMON PAPILLOTOME	Jun 18, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K896612	DOBBHOFF(R) PAPILLOTOME	Feb 12, 1990	Substantially Equivalent	Biosearch Medical Products, Inc.
K896507	PORGES DIATHERMY SNARE	Jan 29, 1990	Substantially Equivalent	Porges Corp.
K896426	PORGES SPHINCTEROTOMES	Jan 22, 1990	Substantially Equivalent	Porges Corp.
K895855	PHOENIX	Jan 22, 1990	Substantially Equivalent	Medical and Scientific Enterprises, Inc.
K895842	BITOME(TM) BIPOLAR SPHINCTEROTOME	Jan 11, 1990	Substantially Equivalent	Everest Medical Corp.
K894861	WILTEK PAPILLOTOME	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K892895	MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM	Sep 25, 1989	Substantially Equivalent	Everest Medical Corp.
K884025	CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200	Mar 03, 1989	Substantially Equivalent	Circon Acmi
K885005	MICROVASIVE GOLD PROBE	Feb 01, 1989	Substantially Equivalent	Boston Scientific Corp
K884254	CIRCON ACMI BICAP III THERAPEUTIC SYSTEM	Jan 11, 1989	Substantially Equivalent	Circon Acmi
K884252	CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20	Jan 10, 1989	Substantially Equivalent	Circon Acmi
K884306	BICAP ABLATING FORCEPS BAF-7	Jan 05, 1989	Substantially Equivalent	Circon Acmi
K882048	MEDITRON ENDOLAV MODEL EL-100	Oct 31, 1988	Substantially Equivalent	Xylog Corp.
K880748	BALL TIP FULGURATING ELECTRODE, 3 FRENCH	Aug 04, 1988	Substantially Equivalent	Cook Urological, Inc.
K870705	THERMAL COAGULATOR	Apr 17, 1987	Substantially Equivalent	Microvasive
K864413	MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE	Dec 09, 1986	Substantially Equivalent	Cooper Lasersonics, Inc.
K861904	HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE	Oct 16, 1986	Substantially Equivalent	Cooper Lasersonics, Inc.
K860593	ET/RT PAPILLOTOME	Jul 22, 1986	Substantially Equivalent	Hobbs Medical, Inc.
K862060	POLYPECTOMY SNARE	Jun 27, 1986	Substantially Equivalent	Endovations
K860366	CHALLENGER HOT BIOPSY FORCEPS	Apr 07, 1986	Substantially Equivalent	Microvasive
K853680	ENDODYNAMIC SIEGEL SPHINCTEROTOME	Nov 04, 1985	Substantially Equivalent	E-Z-Em, Inc.
K851958	ROTATABLE POLYPECTOMY SNARE POS-1	Jul 25, 1985	Substantially Equivalent	Wilson-Cook Medical, Inc.
K851652	PAPILLOTOME	Jun 24, 1985	Substantially Equivalent	Microvasive
K851964	E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE	Jun 13, 1985	Substantially Equivalent	Wilson-Cook Medical, Inc.
K851096	HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM	May 22, 1985	Substantially Equivalent	Olympus Corp.
K845015	DAVOL PAPILLITOME	Jan 15, 1985	Substantially Equivalent	C.R. Bard, Inc.
K842810	INFRARED COAGULATOR	Oct 18, 1984	Substantially Equivalent	Endo Lase, Inc.
K820430	DIATHERMIC SNARES	Apr 08, 1982	Substantially Equivalent	American Endoscopy, Inc.
K820240	PAPILLOTOMES	Mar 26, 1982	Substantially Equivalent	American Endoscopy, Inc.
K820405	GROUND AID CAPHESIVE	Mar 02, 1982	Substantially Equivalent	Promedicon, Inc.
K820196	ELECTROSURGICAL DISP. DISPERSIVE PAD	Feb 12, 1982	Substantially Equivalent	Promedicon, Inc.
K813434	ELECTROSURGICAL DISP. DISPERSIVE PAD	Jan 12, 1982	Substantially Equivalent	Promedicon, Inc.
K812213	AUTOMATED ELECTROCAUTERY SYSTEM	Nov 05, 1981	Substantially Equivalent	University of Washington
K810336	POLYPECTOMY SNARE	Mar 20, 1981	Substantially Equivalent	Medi-Tech, Inc.
K802444	PAPILLOTOME PRODUCT	Oct 23, 1980	Substantially Equivalent	Mill-Rose Laboratory
K800915	JOHNLOZ ENDOSCOPY HANDLE	May 30, 1980	Substantially Equivalent	Endoscopic Surgical Accessories, Inc.
K800975	M.R. ASSOC. TRUE-FEEL HANDLE	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800974	M.R. ASSOC. POWER CORD	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800973	M.R. ASSOC. HOT BIOPSY FORCEPS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800965	M.R. ASSOC. SNARES; CRESCENT SNARE WIRE	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800964	M.R. ASSOC. BALL TYPE COAGULATOR	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800321	CONCEPT SUCTION COAGULATOR	Feb 28, 1980	Substantially Equivalent	Concept, Inc.
K781353	PAPILLOTOME CUTTING SNARE	Oct 10, 1978	Substantially Equivalent	Cameron-Miller, Inc.
K780774	PAPILLOTOMY KNIVES	Jul 27, 1978	Substantially Equivalent	Olympus Corp.
K770280	CORD, ELECTROSURGICAL-STERILE & DISPOS.	Apr 15, 1977	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760178	ELECTRODE, CUTTING LOOP	Oct 15, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.